For the second time in less than six months, Catalent will modernize its sleek new facility in Anagni, Italy, this time to add biologic drug manufacturing capabilities to meet increased demand.
Two new 2,000-liter single-use bioreactors with new manufacturing suites will support early clinical development and late-stage commercial transfers, the company said in a press release, along with space for two more bioreactors to add in the future. The project is expected to add 100 new employees and is expected to be operational in April 2023.
When completed, the expansion will have a manufacturing capacity of 16,000 liters. The lots may range from 2,000 to 8,000 liters. The program will cost around $ 100 million, Catalent said.
The plant was acquired from BMS in 2019 and in response to the pandemic, Catalent has increased its vial filling, inspection, labeling and packaging services. In March, the company announced that it would increase the supply of the J&J Covid-19 vaccine. This agreement extended a vial filling line to align with J&J approval by the FDA.
“Catalent is committed to supporting customers, from small virtual biotech companies to large biopharmaceutical companies who need the right capabilities, scale of capacity and integrated solutions to meet their needs for new biologic treatments and vaccines,” said Mario Gargiulo, President of Regional Biologics for Europe, said in a press release. “Catalent was an early adopter of single-use technology due to its flexibility, and we continue to invest in technology that enables adaptable and scalable solutions for the rapidly growing segment of biologics targeting to medium-sized and orphan patient populations. “
The factory made headlines in March, when Italian police raided it amid complaints that AstraZeneca had stored doses of its vaccine, which AstraZeneca later denied, saying the process was ” complex and long “.
The expansion is in addition to its European operations in Limoges, France, and Brussels, Belgium, and the United States at Madison, WI, and Bloomington, IN. The New Jersey CDMO just completed an expansion of the Wisconsin plant with the goal of producing twice as many Moderna vaccines by the summer. Two new suites with new single-use bioreactors have also been added.
Since the pandemic, there has been a wave of activity within the CDMO industry, and Catalent has been at the forefront of that. Last week, it announced a partnership with Curtana Pharmaceuticals, based in Austin, Texas, to make CT-179, its drug treatment for brain cancer. He also joined the cannabidiol world with a partnership with JOS Pharmaceuticals to study arousal anesthesia using CBD for use in cataract surgeries.